MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT; HIP DISTAL STEM

Model Number	01.36.168
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 29 april 2022: lot 2102623: (b)(4) items manufactured and released on 05-july-2021.Expiration date: 2026-06-21.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold without any similar reported event.
Event or Problem Description
At 3 months after the primary, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised the stem and head.The surgery was completed successfully.
Additional Manufacturer Narrative
This follow up has been sent in order to correct data about: product details, event description, batch review and to report the clinical evaluation analysis.Batch review performed on 03 august 2022 lot 1901220: 30 items manufactured and released on 29-oct-2019.Expiration date: 2024-10-16.No anomalies found related to the problem.To date, 23 items of the same lot have been sold without any similar reported event during the period of review.Clinical evaluation performed by medical affairs department: revision 3 months after the primary tha in a male patient due to pain.After few days from the index surgery a revision occured due to a periprosthetic fracture.The surgeon cabled the fracture and revised the stem and head as shown in the radiographic images provided.According to report, a second revision was done due to subsidence of the stem.No images are provided after the subsidence and the cause is unknown.It may be possible that the cerclage could not hold the loads or that, during the healing process, the dimensions of the femoral canal changed slightly and were no longer able to sustain the stem.As to the question contained in the report that an angle of 2 ° can be not adequate for this purpose, the literature and medical experience of the last 33 years has shown that this design is perfectly suitable for this purpose, so it is not a matter of concern.Additional implants involved: batch review performed on 03 august 2022 on stem: m-vizion 01.22.427 proximal body ø24mm l 40mm lat with holes (k201471) lot.2008338: 21 items manufactured and released on 18-may-2021.Expiration date: 2026-05-03.No anomalies found related to the problem.To date, 2 items of the same lot have been sold without any similar reported event during the period of review.
Event or Problem Description
The patient had a primary hip surgery on (b)(6) 2022.On (b)(6) 2022, the patient came in reporting pain due to a periprosthetic fracture and the cause is unknown.The surgeon cabled the fracture and revised the stem and head.The surgery was completed successfully.Presently, on (b)(6) 2022, the patient came in reporting pain due to a subsided stem and the cause is unknown.The surgeon revised the stem and head.The surgery was completed successfully.

• Brand Name: STEM: M-VIZION DISTAL STEM Ø15MM L 140MM STRAIGHT
• Common Device Name: HIP DISTAL STEM
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 14486034
• Report Number: 3005180920-2022-00399
• Device Sequence Number: 5321551
• Product Code: LZO
• UDI-Device Identifier: 07630030885013
• UDI-Public: 07630030885013
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170690
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/16/2024
• Device Model Number: 01.36.168
• Device Catalogue Number: 01.22.104
• Device Lot Number: 1901220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 05/24/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male